A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RET-rearrangement.
- Conditions
- Advanced stage RET-rearranged NSCLCMedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002063-17-SI
- Lead Sponsor
- ETOP (European Thoracic Oncology Platform)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
- Histologically or cytologically-documented non-small cell lung carcinoma
- Advanced disease defined as recurrent stage IV (according to 8th TNM classification) or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical
resection, or definitive chemo-radiation therapy for locally advanced disease)
- RET rearrangement detected by FISH, Nanostring or by parallel-sequencing on FFPE tumour tissue (biopsy, resection or cytoblock) assessed locally.
- Availability of FFPE tumour material for central confirmation of RET-rearrangement
- At least one prior platinum-based systemic regimen: Adjuvant or neoadjuvant or definitive platinum-based chemo-radiotherapy treatments are considered as a line of treatment only if completed less than 6 months before enrolment. Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate regimen of therapy.
- Measurable or non-measurable, but radiologically evaluable (except for skin lesions) disease according to RECIST v1.1 criteria
- Adequate haematological, renal and liver function
- ECOG Performance Status 0-2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
- Untreated, active CNS metastases
- Carcinomatous meningitis
- Baseline symptomatic bradycardia
- Prior treatment with any RET TKI or RET targeted therapy
- Known EGFR, ALK, ROS, and BRAF mutation (in addition to RET rearrangement)
- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- History of hypersensitivity to any of the additives in the alectinib drug formulation
- Pregnant or lactating women
- Known HIV positivity or AIDS-related illness
- Any concurrent systemic anticancer therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST 1.1.;<br> Secondary Objective: The secondary objectives are to evaluate secondary measures<br> of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and tolerability of the treatment and to describe the<br> association of primary and secondary outcomes with tumour characteristics.<br> ;Primary end point(s): Best overall response (OR = CR or PR), per investigator assessment, according to RECIST 1.1.;<br> Timepoint(s) of evaluation of this end point: from the start of trial treatment across all time points until the end of trial<br> treatment.<br>
- Secondary Outcome Measures
Name Time Method